Device Classification Name |
device, blood mixing and blood weighing
|
510(k) Number |
DK760743 |
Tradename |
DONORMATIC
|
Device Name |
Blood Mixing and Weighing Devices |
Original Applicant |
Lifeline Instruments, Inc. |
1180 miraloma way, suite e |
sunnyvale,
CA
94086
|
|
Regulation Number | 864.9195
|
Classification Product Code |
|
Date Received | 12/01/1976 |
Decision Date | 12/06/1976 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Hematology
|
Review Advisory Committee |
Hematology
|
Type |
510(k) Traditional
|
Total Product Life Cycle (TPLC) |
TPLC Device Report
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
Combination Product |
No
|
In Vitro Product |
No
|
|
|